35 resultados para Medical Design
Resumo:
The medically uninsured population in the United States is 16% or 42 million people and consists of a significant number of Type 2 diabetic patients which is the predominant form of diabetes with 798,000 new cases diagnosed each year. There is limited health services research on uninsured populations concerning health system measures or specific disease conditions. ^ The purpose of this investigation was to determine the impact a newly implemented health care program had on the quality of care provided to patients with Type 2 diabetes. The primary study objective was to compare the quality of care while controlling for utilization, and health status of patients in the new program to their status during the previous financial assistance program. The research design was a retrospective matched-pairs design. The study population consisted of 225 patients who received medical care during 1996 and 1997 at the University Health System in San Antonio, Texas. ^ Six quality of care measures individually failed to demonstrate a statistically significant difference when compared between the two periods. However, an index measure reflecting the number of patients who received all six of the quality of care measures demonstrated a statistically significant increase in 1997 (p-value < 0.05). In 1996, 8 patients (2.6%) received all six medical management components. In 1997, 38 patients (16.8%) received all six medical management components. Four regression models were analyzed; two out of the four models demonstrated inconsistent results based on the program membership variable. ^ It is concluded that there has been a small effect of the Carelink program demonstrated by an increase from 8 to 38 patients receiving all quality of care components for Type 2 diabetics at the UHS. It is recommended that additional research be conducted in order to evaluate the quality of care provided to Type 2 diabetic patients. ^
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Many phase II clinical studies in oncology use two-stage frequentist design such as Simon's optimal design. However, they have a common logistical problem regarding the patient accrual at the interim. Strictly speaking, patient accrual at the end of the first stage may have to be suspended until all patients have events, success or failure. For example, when the study endpoint is six-month progression free survival, patient accrual has to be stopped until all outcomes from stage I is observed. However, study investigators may have concern when accrual is suspended after the first stage due to the loss of accrual momentum during this hiatus. We propose a two-stage phase II design that resolves the patient accrual problem due to an interim analysis, and it can be used as an alternative way to frequentist two-stage phase II studies in oncology. ^
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The usage of intensity modulated radiotherapy (IMRT) treatments necessitates a significant amount of patient-specific quality assurance (QA). This research has investigated the precision and accuracy of Kodak EDR2 film measurements for IMRT verifications, the use of comparisons between 2D dose calculations and measurements to improve treatment plan beam models, and the dosimetric impact of delivery errors. New measurement techniques and software were developed and used clinically at M. D. Anderson Cancer Center. The software implemented two new dose comparison parameters, the 2D normalized agreement test (NAT) and the scalar NAT index. A single-film calibration technique using multileaf collimator (MLC) delivery was developed. EDR2 film's optical density response was found to be sensitive to several factors: radiation time, length of time between exposure and processing, and phantom material. Precision of EDR2 film measurements was found to be better than 1%. For IMRT verification, EDR2 film measurements agreed with ion chamber results to 2%/2mm accuracy for single-beam fluence map verifications and to 5%/2mm for transverse plane measurements of complete plan dose distributions. The same system was used to quantitatively optimize the radiation field offset and MLC transmission beam modeling parameters for Varian MLCs. While scalar dose comparison metrics can work well for optimization purposes, the influence of external parameters on the dose discrepancies must be minimized. The ability of 2D verifications to detect delivery errors was tested with simulated data. The dosimetric characteristics of delivery errors were compared to patient-specific clinical IMRT verifications. For the clinical verifications, the NAT index and percent of pixels failing the gamma index were exponentially distributed and dependent upon the measurement phantom but not the treatment site. Delivery errors affecting all beams in the treatment plan were flagged by the NAT index, although delivery errors impacting only one beam could not be differentiated from routine clinical verification discrepancies. Clinical use of this system will flag outliers, allow physicists to examine their causes, and perhaps improve the level of agreement between radiation dose distribution measurements and calculations. The principles used to design and evaluate this system are extensible to future multidimensional dose measurements and comparisons. ^
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Statement of the problem and public health significance. Hospitals were designed to be a safe haven and respite from disease and illness. However, a large body of evidence points to preventable errors in hospitals as the eighth leading cause of death among Americans. Twelve percent of Americans, or over 33.8 million people, are hospitalized each year. This population represents a significant portion of at risk citizens exposed to hospital medical errors. Since the number of annual deaths due to hospital medical errors is estimated to exceed 44,000, the magnitude of this tragedy makes it a significant public health problem. ^ Specific aims. The specific aims of this study were threefold. First, this study aimed to analyze the state of the states' mandatory hospital medical error reporting six years after the release of the influential IOM report, "To Err is Human." The second aim was to identify barriers to reporting of medical errors by hospital personnel. The third aim was to identify hospital safety measures implemented to reduce medical errors and enhance patient safety. ^ Methods. A descriptive, longitudinal, retrospective design was used to address the first stated objective. The study data came from the twenty-one states with mandatory hospital reporting programs which report aggregate hospital error data that is accessible to the public by way of states' websites. The data analysis included calculations of expected number of medical errors for each state according to IOM rates. Where possible, a comparison was made between state reported data and the calculated IOM expected number of errors. A literature review was performed to achieve the second study aim, identifying barriers to reporting medical errors. The final aim was accomplished by telephone interviews of principal patient safety/quality officers from five Texas hospitals with more than 700 beds. ^ Results. The state medical error data suggests vast underreporting of hospital medical errors to the states. The telephone interviews suggest that hospitals are working at reducing medical errors and creating safer environments for patients. The literature review suggests the underreporting of medical errors at the state level stems from underreporting of errors at the delivery level. ^
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In a large health care system, the importance of accurate information as feedback mechanisms about its performance is necessary on many levels from the senior level management to service level managers for valid decision-making purposes. The implementation of dashboards is one way to remedy the problem of data overload by providing up-to-date, accurate, and concise information. As this health care system seeks to have an organized, systematic review mechanism in place, dashboards are being created in a variety of the hospital service departments to monitor performance indicators. The Infection Control Administration of this health care system is one that does not currently utilize a dashboard but seeks to implement one. ^ The purpose of this project is to research and design a clinical dashboard for the Infection Control Administration. The intent is that the implementation and usefulness of the clinical dashboard translates into improvement in the measurement of health care quality.^
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Objectives. To investigate procedural gender equity by assessing predisposing, enabling and need predictors of gender differences in annual medical expenditures and utilization among hypertensive individuals in the U.S. Also, to estimate and compare lifetime medical expenditures among hypertensive men and women in the U.S. ^ Data source. 2001-2004 the Medical Expenditure Panel Survey (MEPS);1986-2000 National Health Interview Survey (NHIS) and National Health Interview Survey linked to mortality in the National Death Index through 2002 (2002 NHIS-NDI). ^ Study design. We estimated total medical expenditure using four equations regression model, specific medical expenditures using two equations regression model and utilization using negative binomial regression model. Procedural equity was assessed by applying the Aday et al. theoretical framework. Expenditures were estimated in 2004 dollars. We estimated hypertension-attributable medical expenditure and utilization among men and women. ^ To estimate lifetime expenditures from ages 20 to 85+, we estimated medical expenditures with cross-sectional data and survival with prospective data. The four equations regression model were used to estimate average annual medical expenditures defined as sum of inpatient stay, emergency room visits, outpatient visits, office based visits, and prescription drugs expenditures. Life tables were used to estimate the distribution of life time medical expenditures for hypertensive men and women at different age and factors such as disease incidence, medical technology and health care cost were assumed to be fixed. Both total and hypertension attributable expenditures among men and women were estimated. ^ Data collection. We used the 2001-2004 MEPS household component and medical condition files; the NHIS person and condition files from 1986-1996 and 1997-2000 sample adult files were used; and the 1986-2000 NHIS that were linked to mortality in the 2002 NHIS-NDI. ^ Principal findings. Hypertensive men had significantly less utilization for most measures after controlling predisposing, enabling and need factors than hypertensive women. Similarly, hypertensive men had less prescription drug (-9.3%), office based (-7.2%) and total medical (-4.5%) expenditures than hypertensive women. However, men had more hypertension-attributable medical expenditures and utilization than women. ^ Expected total lifetime expenditure for average life table individuals at age 20, was $188,300 for hypertensive men and $254,910 for hypertensive women. But the lifetime expenditure that could be attributed to hypertension was $88,033 for men and $40,960 for women. ^ Conclusion. Hypertensive women had more utilization and expenditure for most measures than hypertensive men, possibly indicating procedural inequity. However, relatively higher hypertension-attributable health care of men shows more utilization of resources to treat hypertension related diseases among men than women. Similar results were reported in lifetime analyses.^ Key words: gender, medical expenditures, utilization, hypertension-attributable, lifetime expenditure ^
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In recent years, disaster preparedness through assessment of medical and special needs persons (MSNP) has taken a center place in public eye in effect of frequent natural disasters such as hurricanes, storm surge or tsunami due to climate change and increased human activity on our planet. Statistical methods complex survey design and analysis have equally gained significance as a consequence. However, there exist many challenges still, to infer such assessments over the target population for policy level advocacy and implementation. ^ Objective. This study discusses the use of some of the statistical methods for disaster preparedness and medical needs assessment to facilitate local and state governments for its policy level decision making and logistic support to avoid any loss of life and property in future calamities. ^ Methods. In order to obtain precise and unbiased estimates for Medical Special Needs Persons (MSNP) and disaster preparedness for evacuation in Rio Grande Valley (RGV) of Texas, a stratified and cluster-randomized multi-stage sampling design was implemented. US School of Public Health, Brownsville surveyed 3088 households in three counties namely Cameron, Hidalgo, and Willacy. Multiple statistical methods were implemented and estimates were obtained taking into count probability of selection and clustering effects. Statistical methods for data analysis discussed were Multivariate Linear Regression (MLR), Survey Linear Regression (Svy-Reg), Generalized Estimation Equation (GEE) and Multilevel Mixed Models (MLM) all with and without sampling weights. ^ Results. Estimated population for RGV was 1,146,796. There were 51.5% female, 90% Hispanic, 73% married, 56% unemployed and 37% with their personal transport. 40% people attained education up to elementary school, another 42% reaching high school and only 18% went to college. Median household income is less than $15,000/year. MSNP estimated to be 44,196 (3.98%) [95% CI: 39,029; 51,123]. All statistical models are in concordance with MSNP estimates ranging from 44,000 to 48,000. MSNP estimates for statistical methods are: MLR (47,707; 95% CI: 42,462; 52,999), MLR with weights (45,882; 95% CI: 39,792; 51,972), Bootstrap Regression (47,730; 95% CI: 41,629; 53,785), GEE (47,649; 95% CI: 41,629; 53,670), GEE with weights (45,076; 95% CI: 39,029; 51,123), Svy-Reg (44,196; 95% CI: 40,004; 48,390) and MLM (46,513; 95% CI: 39,869; 53,157). ^ Conclusion. RGV is a flood zone, most susceptible to hurricanes and other natural disasters. People in the region are mostly Hispanic, under-educated with least income levels in the U.S. In case of any disaster people in large are incapacitated with only 37% have their personal transport to take care of MSNP. Local and state government’s intervention in terms of planning, preparation and support for evacuation is necessary in any such disaster to avoid loss of precious human life. ^ Key words: Complex Surveys, statistical methods, multilevel models, cluster randomized, sampling weights, raking, survey regression, generalized estimation equations (GEE), random effects, Intracluster correlation coefficient (ICC).^
Resumo:
Cross-sectional designs, longitudinal designs in which a single cohort is followed over time, and mixed-longitudinal designs in which several cohorts are followed for a shorter period are compared by their precision, potential for bias due to age, time and cohort effects, and feasibility. Mixed longitudinal studies have two advantages over longitudinal studies: isolation of time and age effects and shorter completion time. Though the advantages of mixed-longitudinal studies are clear, choosing an optimal design is difficult, especially given the number of possible combinations of the number of cohorts and number of overlapping intervals between cohorts. The purpose of this paper is to determine the optimal design for detecting differences in group growth rates.^ The type of mixed-longitudinal study appropriate for modeling both individual and group growth rates is called a "multiple-longitudinal" design. A multiple-longitudinal study typically requires uniform or simultaneous entry of subjects, who are each observed till the end of the study.^ While recommendations for designing pure-longitudinal studies have been made by Schlesselman (1973b), Lefant (1990) and Helms (1991), design recommendations for multiple-longitudinal studies have never been published. It is shown that by using power analyses to determine the minimum number of occasions per cohort and minimum number of overlapping occasions between cohorts, in conjunction with a cost model, an optimal multiple-longitudinal design can be determined. An example of systolic blood pressure values for cohorts of males and cohorts of females, ages 8 to 18 years, is given. ^
Resumo:
Conventional designs of animal bioassays allocate the same number of animals into control and dose groups to explore the spontaneous and induced tumor incidence rates, respectively. The purpose of such bioassays are (a) to determine whether or not the substance exhibits carcinogenic properties, and (b) if so, to estimate the human response at relatively low doses. In this study, it has been found that the optimal allocation to the experimental groups which, in some sense, minimize the error of the estimated response for low dose extrapolation is associated with the dose level and tumor risk. The number of dose levels has been investigated at the affordable experimental cost. The pattern of the administered dose, 1 MTD, 1/2 MTD, 1/4 MTD,....., etc. plus control, gives the most reasonable arrangement for the low dose extrapolation purpose. The arrangement of five dose groups may make the highest dose trivial. A four-dose design can circumvent this problem and has also one degree of freedom for testing the goodness-of-fit of the response model.^ An example using the data on liver tumors induced in mice in a lifetime study of feeding dieldrin (Walker et al., 1973) is implemented with the methodology. The results are compared with conclusions drawn from other studies. ^
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Objective. This research study had two goals: (1) to describe resource consumption patterns for Medi-Cal children with cystic fibrosis, and (2) to explore the feasibility from a rate design perspective of developing specialized managed care plans for such a special needs population.^ Background. Children with special health care needs (CSHN) comprise about 2% of the California Medicaid pediatric population. CSHN have rare but serious health problems, such as cystic fibrosis. Medicaid programs, including Medi-Cal, are enrolling more and more beneficiaries in managed care to control costs. CSHN, however, do not fit the wellness model underlying most managed care plans. Child health advocates believe that both efficiency and quality will suffer if CSHN are removed from regionalized special care centers and scattered among general purpose plans. They believe that CSHN should be "carved out" from enrollment in general plans. One alternative is the Specialized Managed Care Plan, tailored for CSHN.^ Methods. The study population consisted of children under age 21 with CF who were eligible for Medi-Cal and California Children's Services program (CCS) during 1991. Health Care Financing Administration (HCFA) Medicaid Tape-to-Tape data were analyzed as part of a California Children's Hospital Association (CCHA) project.^ Results. Mean Medi-Cal expenditures per month enrolled were $2,302 for 457 CF children, compared to about \$1,270 for all 47,000 CCS special needs children and roughly $60 for almost 2.6 million ``regular needs'' children. For CF children, inpatient care (80\%) and outpatient drugs (9\%) were the major cost drivers, with {\it all\/} outpatient visits comprising only 2\% of expenditures. About one-third of CF children were eligible due to AFDC (Aid to Families with Dependent Children). Age group explained about 17\% of all expenditure variation. Regression analysis was used to select the best capitation rate structure (rate cells by age and eligibility group). Sensitivity analysis estimated moderate financial risk for a statewide plan (360 enrollees), but severe risk for single county implementation due to small numbers of children.^ Conclusions. Study results support the carve out of CSHN due to unique expenditure patterns. The Specialized Managed Care Plan concept appears feasible from a rate design perspective given sufficient enrollees. ^
Resumo:
Mixed longitudinal designs are important study designs for many areas of medical research. Mixed longitudinal studies have several advantages over cross-sectional or pure longitudinal studies, including shorter study completion time and ability to separate time and age effects, thus are an attractive choice. Statistical methodology used in general longitudinal studies has been rapidly developing within the last few decades. Common approaches for statistical modeling in studies with mixed longitudinal designs have been the linear mixed-effects model incorporating an age or time effect. The general linear mixed-effects model is considered an appropriate choice to analyze repeated measurements data in longitudinal studies. However, common use of linear mixed-effects model on mixed longitudinal studies often incorporates age as the only random-effect but fails to take into consideration the cohort effect in conducting statistical inferences on age-related trajectories of outcome measurements. We believe special attention should be paid to cohort effects when analyzing data in mixed longitudinal designs with multiple overlapping cohorts. Thus, this has become an important statistical issue to address. ^ This research aims to address statistical issues related to mixed longitudinal studies. The proposed study examined the existing statistical analysis methods for the mixed longitudinal designs and developed an alternative analytic method to incorporate effects from multiple overlapping cohorts as well as from different aged subjects. The proposed study used simulation to evaluate the performance of the proposed analytic method by comparing it with the commonly-used model. Finally, the study applied the proposed analytic method to the data collected by an existing study Project HeartBeat!, which had been evaluated using traditional analytic techniques. Project HeartBeat! is a longitudinal study of cardiovascular disease (CVD) risk factors in childhood and adolescence using a mixed longitudinal design. The proposed model was used to evaluate four blood lipids adjusting for age, gender, race/ethnicity, and endocrine hormones. The result of this dissertation suggest the proposed analytic model could be a more flexible and reliable choice than the traditional model in terms of fitting data to provide more accurate estimates in mixed longitudinal studies. Conceptually, the proposed model described in this study has useful features, including consideration of effects from multiple overlapping cohorts, and is an attractive approach for analyzing data in mixed longitudinal design studies.^
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Background: Hypertension and Diabetes is a public health and economic concern in the United States. The utilization of medical home concepts increases the receipt of preventive services, however, do they also increase adherence to treatments? This study examined the effect of patient-centered medical home technologies such as the electronic health record, clinical support system, and web-based care management in improving health outcomes related to hypertension and diabetes. Methods: A systematic review of the literature used a best evidence synthesis approach to address the general question " Do patient-centered medical home technologies have an effect of diabetes and hypertension treatment?" This was followed by an evaluation of specific examples of the technologies utilized such as computer-assisted recommendations and web-based care management provided by the patient's electronic health record. Ebsco host, Ovid host, and Google Scholar were the databases used to conduct the literature search. Results: The initial search identified over 25 studies based on content and quality that implemented technology interventions to improve communication between provider and patient. After further assessing the articles for risk of bias and study design, 13 randomized controlled studies were chosen. All of the studies chosen were conducted in various primary care settings in both private practices and hospitals between the years 2000 and 2007. The sample sizes of the studies ranged from 42 to 2924 participants. The mean age for all of the studies ranged from 56 to 71 years. The percent women in the studies ranged from one to 78 percent. Over one-third of the studies did not provide the racial composition of the participants. For the seven studies that did provide information about the ethnic composition, 64% of the intervention participants were White. All of the studies utilized some type of web-based or computer-based communication to manage hypertension or diabetes care. Findings on outcomes were mixed, with nine out of 13 studies showing no significant effect on outcomes examined, and four of the studies showing significant and positive impact on health outcomes related to hypertension or diabetes Conclusion: Although the technologies improved patient and provider satisfaction, the outcomes measures such as blood pressure control and glucose control were inconclusive. Further research is needed with diverse ethnic and SES population to investigate the role of patient-centered technologies on hypertension and diabetes control. Also, further research is needed to investigate the effects of innovative medical home technologies that can be used by both patients and providers to increase quality of communication concerning adherence to treatments.^
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High-resolution, small-bore PET systems suffer from a tradeoff between system sensitivity, and image quality degradation. In these systems long crystals allow mispositioning of the line of response due to parallax error and this mispositioning causes resolution blurring, but long crystals are necessary for high system sensitivity. One means to allow long crystals without introducing parallax errors is to determine the depth of interaction (DOI) of the gamma ray interaction within the detector module. While DOI has been investigated previously, newly available solid state photomultipliers (SSPMs) well-suited to PET applications and allow new modules for investigation. Depth of interaction in full modules is a relatively new field, and so even if high performance DOI capable modules were available, the appropriate means to characterize and calibrate the modules are not. This work presents an investigation of DOI capable arrays and techniques for characterizing and calibrating those modules. The methods introduced here accurately and reliably characterize and calibrate energy, timing, and event interaction positioning. Additionally presented is a characterization of the spatial resolution of DOI capable modules and a measurement of DOI effects for different angles between detector modules. These arrays have been built into a prototype PET system that delivers better than 2.0 mm resolution with a single-sided-stopping-power in excess of 95% for 511 keV g's. The noise properties of SSPMs scale with the active area of the detector face, and so the best signal-to-noise ratio is possible with parallel readout of each SSPM photodetector pixel rather than multiplexing signals together. This work additionally investigates several algorithms for improving timing performance using timing information from multiple SSPM pixels when light is distributed among several photodetectors.
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The influence of respiratory motion on patient anatomy poses a challenge to accurate radiation therapy, especially in lung cancer treatment. Modern radiation therapy planning uses models of tumor respiratory motion to account for target motion in targeting. The tumor motion model can be verified on a per-treatment session basis with four-dimensional cone-beam computed tomography (4D-CBCT), which acquires an image set of the dynamic target throughout the respiratory cycle during the therapy session. 4D-CBCT is undersampled if the scan time is too short. However, short scan time is desirable in clinical practice to reduce patient setup time. This dissertation presents the design and optimization of 4D-CBCT to reduce the impact of undersampling artifacts with short scan times. This work measures the impact of undersampling artifacts on the accuracy of target motion measurement under different sampling conditions and for various object sizes and motions. The results provide a minimum scan time such that the target tracking error is less than a specified tolerance. This work also presents new image reconstruction algorithms for reducing undersampling artifacts in undersampled datasets by taking advantage of the assumption that the relevant motion of interest is contained within a volume-of-interest (VOI). It is shown that the VOI-based reconstruction provides more accurate image intensity than standard reconstruction. The VOI-based reconstruction produced 43% fewer least-squares error inside the VOI and 84% fewer error throughout the image in a study designed to simulate target motion. The VOI-based reconstruction approach can reduce acquisition time and improve image quality in 4D-CBCT.
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The purpose of this study was to design, synthesize and develop novel transporter targeting agents for image-guided therapy and drug delivery. Two novel agents, N4-guanine (N4amG) and glycopeptide (GP) were synthesized for tumor cell proliferation assessment and cancer theranostic platform, respectively. N4amG and GP were synthesized and radiolabeled with 99mTc and 68Ga. The chemical and radiochemical purities as well as radiochemical stabilities of radiolabeled N4amG and GP were tested. In vitro stability assessment showed both 99mTc-N4amG and 99mTc-GP were stable up to 6 hours, whereas 68Ga-GP was stable up to 2 hours. Cell culture studies confirmed radiolabeled N4amG and GP could penetrate the cell membrane through nucleoside transporters and amino acid transporters, respectively. Up to 40% of intracellular 99mTc-N4amG and 99mTc-GP was found within cell nucleus following 2 hours of incubation. Flow cytometry analysis revealed 99mTc-N4amG was a cell cycle S phase-specific agent. There was a significant difference of the uptake of 99mTc-GP between pre- and post- paclitaxel-treated cells, which suggests that 99mTc-GP may be useful in chemotherapy treatment monitoring. Moreover, radiolabeled N4amG and GP were tested in vivo using tumor-bearing animal models. 99mTc-N4amG showed an increase in tumor-to-muscle count density ratios up to 5 at 4 hour imaging. Both 99mTc-labeled agents showed decreased tumor uptake after paclitaxel treatment. Immunohistochemistry analysis demonstrated that the uptake of 99mTc-N4amG was correlated with Ki-67 expression. Both 99mTc-N4amG and 99mTc-GP could differentiate between tumor and inflammation in animal studies. Furthermore, 68Ga-GP was compared to 18F-FDG in rabbit PET imaging studies. 68Ga-GP had lower tumor standardized uptake values (SUV), but similar uptake dynamics, and different biodistribution compared with 18F-FDG. Finally, to demonstrate that GP can be a potential drug carrier for cancer theranostics, several drugs, including doxorubicin, were selected to be conjugated to GP. Imaging studies demonstrated that tumor uptake of GP-drug conjugates was increased as a function of time. GP-doxorubicin (GP-DOX) showed a slow-release pattern in in vitro cytotoxicity assay and exhibited anti-cancer efficacy with reduced toxicity in in vivo tumor growth delay study. In conclusion, both N4amG and GP are transporter-based targeting agents. Radiolabeled N4amG can be used for tumor cell proliferation assessment. GP is a potential agent for image-guided therapy and drug delivery.